资讯

Fierce Pharma20 分钟
Vinay Prasad's exit signals FDA's probable slip toward more permissive regulation of cell ...
But this time, the unknown is hitting the industry in a different way from when Prasad was tapped to lead CBER less than ...
Andover Townsman4 小时
493 employees laid off at biopharmaceutical company with operations in Andover
A biopharmaceutical research company with ties in Andover has laid off a third of its workforce as one of the leaders in gene therapy goes through a “strategic ...
TipRanks on MSN15 小时
Sarepta Stock (SRPT) Rallies on FDA Nod for Broader Gene Therapy Use
Shares of Sarepta Therapeutics ($SRPT) jumped over 14% on Tuesday after the FDA authorized the company to restart shipments ...
Vinay Prasad vs the FDA: How One Doctor's Policies Collided with Politics and Cost Him His Job
Dr Vinay Prasad, the FDA's Chief Medical and Scientific Officer, resigned from his post on 29 July 2025 after mounting ...
STAT17 小时Opinion
Vinay Prasad was not good for the FDA. But his ouster makes things worse
Vinay Prasad’s three-month tenure as one of the top officials at the Food and Drug Administration was bad for medicine. But ...
Public Broadcasting Service (PBS)17 小时
Controversial FDA vaccine chief departs agency after less than 3 months
Dr. Vinay Prasad is stepping down as the Food and Drug Administration’s top vaccine regulator after a brief tenure. A ...
BioSpace18 小时
New CDER Head Tidmarsh Will Sub In At Biologics Group After Prasad’s Exit
George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a ...
Business Wire14 天
Rocket Pharmaceuticals Receives FDA Regenerative Medicine Advanced ...
Rocket has also received IND clearance for its AAV-based gene therapy for BAG3-associated dilated cardiomyopathy (DCM), a heart failure condition that causes enlarged ventricles.
news.bloomberglaw14 天
Sarepta Cuts Workforce After Patient Deaths on Gene Therapy (1)
Sarepta Therapeutics Inc. shares soared after the company said it was cutting more than a third of its workforce and that its gene therapy for a fatal muscle disorder would stay on the market with ...
Managed Healthcare Executive14 天
Applying Evidence Standards to Guide Gene Therapy Use in BCG ...
An expert discusses how high-cost gene therapies require evidence standards including Phase 3 trial data showing complete response rates and durability, real-world evidence and health economic ...
Reuters14 天
Sarepta to cut 500 jobs, add black-box warning on gene therapy
Sarepta Therapeutics will cut 500 jobs and add a serious warning on the label of its muscle-disorder gene therapy Elevidys, the drugmaker said on Wednesday, following the recent deaths of two ...